Back to resultsA Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma
Primary Purpose
Melanosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salicylic Acid Peels
Glycolic Acid Peels
Sponsored by
About this trial
This is an interventional treatment trial for Melanosis
Eligibility Criteria
Inclusion Criteria:
- Subjects aged 18 years or older
- Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
- Subjects in general good health
- Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
- Subjects must be willing to not apply other treatment options for melasma during the course of the study
Exclusion Criteria:
- Subjects under 18 years of age
- Subjects who are pregnant and/or lactating
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects diagnosed with mental illness
- Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
- Subjects who have had a chemical peel in the past 3 months
- Subjects who have used a prescribed retinoid in the past 3 months
- Subjects with a bleeding disorder
- Subjects with a history of abnormal wound healing
- Subjects with a history of abnormal scarring
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Salicylic Acid Peels
Glycolic Acid Peels
Arm Description
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
Outcomes
Primary Outcome Measures
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).
Secondary Outcome Measures
Full Information
NCT ID
NCT01976286
First Posted
October 15, 2013
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01976286
Brief Title
A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma
Official Title
A Pilot Study Comparing the Efficacy of Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.
Detailed Description
Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salicylic Acid Peels
Arm Type
Active Comparator
Arm Description
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
Arm Title
Glycolic Acid Peels
Arm Type
Active Comparator
Arm Description
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
Intervention Type
Other
Intervention Name(s)
Salicylic Acid Peels
Intervention Type
Other
Intervention Name(s)
Glycolic Acid Peels
Primary Outcome Measure Information:
Title
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
Description
The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).
Time Frame
1 hour at baseline and week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects aged 18 years or older
Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
Subjects in general good health
Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
Subjects must be willing to not apply other treatment options for melasma during the course of the study
Exclusion Criteria:
Subjects under 18 years of age
Subjects who are pregnant and/or lactating
Subjects who are unable to understand the protocol or to give informed consent
Subjects diagnosed with mental illness
Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
Subjects who have had a chemical peel in the past 3 months
Subjects who have used a prescribed retinoid in the past 3 months
Subjects with a bleeding disorder
Subjects with a history of abnormal wound healing
Subjects with a history of abnormal scarring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma
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